All you need to know about equipment validation for sterility testing.

Abstract

Product sterility testing requests are becoming increasingly common in clinical microbiology laboratories due to the rapid development of advanced therapies. Most laboratory directors are hesitant to bring on such tests because they fall under current Good Manufacturing Practices (cGMP) regulated by the United States Food and Drug Administration (FDA), where expectations differ from clinical requirements (regulated by the Centers for Medicare and Medicaid Services). When considerations are made for cGMP testing in the clinical lab, most focus is placed on analytical test validation. In this mini-review, we provide an overview of one critical element within the cGMP quality system-validation of equipment, software, and systems through installation, operational, and performance qualification (IQ, OQ, and PQ or IOPQ). This terminology is not common in clinical laboratories, and the IQ and OQ portions are often overlooked, not performed, and/or not documented, although phase II CAP requirements exist (COM.30550 and COM.30575). This mini-review will provide an overview of the IOPQ framework, what is included and how it differs from CAP requirements, important considerations for an IOPQ, and a summary of FDA citations relating to equipment validation. We provide examples using blood culture systems, controlled temperature units (CTUs; e.g., incubator), and the laboratory information management system, given their likelihood for use in cGMP activities in the clinical lab. Importantly, the IOPQ requirements summarized here would have also been relevant to laboratory-developed tests (LDTs) classified as "devices" prior to the March 31, 2025, annulment of the ruling.